Lung Cancer Clinical Trial

A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma

Summary

The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).

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Full Description

The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.

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Eligibility Criteria

Inclusion Criteria:

Confirmation of cancer by biopsy (tissue sample)
Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate renal, liver and bone marrow function.
Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Institutional Review Board (IRB) approved, signed and dated informed consent form

Exclusion Criteria:

Prior treatment with study medications
Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept

Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:

Severe cardiovascular disease or event
Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy
Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
Deep vein thrombosis, pulmonary embolism, or other clotting event
Episode(s)of moderate to severe, continuous bleeding
Breast-feeding or pregnancy

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT00794417

Recruitment Status:

Terminated

Sponsor:

Regeneron Pharmaceuticals

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There are 15 Locations for this study

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Arizona Cancer Institute, LLC
Tucson Arizona, 85715, United States
University of Arkansas for Medical Science
Little Rock Arkansas, 72205, United States
Stanford University Medical Center
Stanford California, 94305, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach Florida, 33435, United States
Edward Hines Jr. VA Medical Center
Hines Illinois, 60141, United States
Kentucky Cancer Clinic
Hazard Kentucky, 41701, United States
Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
UNM Cancer Clinic
Albuquerque New Mexico, 87131, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Presbyterian Hospital Center for Cancer Research
Charlotte North Carolina, 28204, United States
Erie Regional Cancer Center
Erie Pennsylvania, 16505, United States
Schiffler Cancer Center - Medical Oncology Division
Wheeling West Virginia, 26003, United States
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT00794417

Recruitment Status:

Terminated

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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